Trial Condition(s):

Venous thrombosis, Deep Vein Thrombosis

Deep vein thrombosis treatment with the Oral Direct Factor Xa Inhibitor Rivaroxaban in patients using a strong CYP 3A4 inducer

Bayer Identifier:

13238

ClinicalTrials.gov Identifier:

NCT00786422

EudraCT Number:

2008-003303-31

Study Completed

Trial Purpose

This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Inclusion Criteria
- Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
  - Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)
Exclusion Criteria
- Legal lower age limitations (country specific)
 - Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism 
 - Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
  - Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) 
 - Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort

Trial Summary

Enrollment Goal
25
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Dr. P. Baron von Bilderling

München, Germany, 80331

Status
Terminated
 
Locations

Academisch Medisch Centrum Universiteit van Amsterdam

AMSTERDAM, Netherlands, 1105 AZ

Status
Terminated
 
Locations

Mayo Clinic

Roodepoort, South Africa, 1724

Status
Terminated
 
Locations

Unitas Hospital

Pretoria, South Africa, 0157

Status
Terminated
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Terminated
 
Locations

Redcliffe District Hospital

Redcliffe, Australia, 4020

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Terminated
 
Locations

University of Debrecen

Debrecen, Hungary, 4032

Status
Terminated
 
Locations

Real Benemérita Ass Portug Beneficiência-Hosp S. Joaquim

São Paulo, Brazil, 01323-001

Status
Terminated
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Terminated
 
Locations

Pretoria Academic Hospital New

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Helderberg Medical Clinical Trials

Somerset West, South Africa, 7130

Status
Terminated
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2132

Status
Completed
 
Locations

Clinical Projects Research SA

Worcester, South Africa, 6850

Status
Terminated
 
Locations

Folateng Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa, 2193

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Terminated
 

Trial Design